Last month, FDA established a public docket, to discuss with industry, issues related to reserving proprietary names for drug products. FDA and industry stakeholders have expressed interest in the past with exploring the possibility of ‘‘reserving’’ proprietary names for companies once the names have been tentatively accepted by the Agency.

Eliminating “tentative approvals” and instead permitting “name reservations” early in the approval process would hopefully provide sponsors with initial clarity and confidence in moving forward to the final stages of product development and marketing.

FDA invites comments on all matters related to a potential program for reserving names for drug products and is particularly interested in obtaining feedback and details from industry. Below is a list of some, but not all, of the matters they are asking for input on:

Examples of drug market launches being delayed, the length of the delay and drugs launched without a proprietary name due to name rejection by the FDA

Potential approaches for reserving proprietary names that would create more “certainty” for applicants than the current tentative acceptance

How the program would create certainty while balancing/minimizing risks of medication errors

Parameters that would be necessary – voluntary vs. mandatory

The number of applicants that would be interested in participating in a “voluntary name reservation program”

What mechanisms can be used to provide notice to an applicant of possible confusion between its proposed brand name and other proposed brand names in pending applications

The docket will be open for public comments until October 27, 2014. Pleaseclick here to view the docket and submit your comments. Med-ERRS highly encourages our industry clients and colleagues to submit their experiences and comments to the docket. We will be submitting our feedback later this month.

If you have any questions regarding the docket, please visit the FDA website atwww.fda.gov.

Med-ERRS will attend this year's Fall PTMG conference in Chicago in early October. We are particularly excited to hear Kellie Taylor's perspectives and updates on the recent developments in FDA’s review of proprietary names for pharmaceuticals.

For those who are attending the conference and are interested in meeting with us, please email Diane Bernstein at dbernstein@med-errs.com.

A pharmacist recently alerted us to the look-alike bottles of traZODONE and traMADOL from Teva (Figure 1). The pharmacist indicated that she has intercepted errors involving these products before they reached the patient. Both products share multiple characteristics that contribute to the problem, including: 1) look-alike names; 2) same dosage strength; 3) same color scheme used for the dosage strength, tablet count, and manufacturer name; 4) same color used for the bottle caps; and 5) the products may be stored near one another on pharmacy shelves. ISMP has notified the US FDA and has asked Teva to take steps to change the packaging of these products.

Key Takeaway: It is crucial for sponsors to evaluate their product's name in combination with its product packaging and design to minimize the chance of medication errors occurring.

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